EP2877121B1 - Trans-aortic surgical syringe-type device for deployment of a prosthetic valve - Google Patents
Trans-aortic surgical syringe-type device for deployment of a prosthetic valve Download PDFInfo
- Publication number
- EP2877121B1 EP2877121B1 EP13733143.5A EP13733143A EP2877121B1 EP 2877121 B1 EP2877121 B1 EP 2877121B1 EP 13733143 A EP13733143 A EP 13733143A EP 2877121 B1 EP2877121 B1 EP 2877121B1
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- EP
- European Patent Office
- Prior art keywords
- prosthetic valve
- valve
- deployment
- deployment element
- delivery shaft
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
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Links
- 239000002775 capsule Substances 0.000 claims description 12
- 210000003709 heart valve Anatomy 0.000 claims description 11
- 230000002439 hemostatic effect Effects 0.000 claims description 9
- 238000003780 insertion Methods 0.000 claims description 7
- 230000037431 insertion Effects 0.000 claims description 7
- 210000000709 aorta Anatomy 0.000 description 21
- 238000000034 method Methods 0.000 description 18
- 210000003811 finger Anatomy 0.000 description 12
- 238000002513 implantation Methods 0.000 description 8
- 210000001765 aortic valve Anatomy 0.000 description 6
- 210000003291 sinus of valsalva Anatomy 0.000 description 6
- 210000002376 aorta thoracic Anatomy 0.000 description 4
- 230000002612 cardiopulmonary effect Effects 0.000 description 4
- 230000002950 deficient Effects 0.000 description 4
- 238000002059 diagnostic imaging Methods 0.000 description 3
- 238000012986 modification Methods 0.000 description 3
- 230000004048 modification Effects 0.000 description 3
- 210000003813 thumb Anatomy 0.000 description 3
- 238000013459 approach Methods 0.000 description 2
- 210000000038 chest Anatomy 0.000 description 2
- 210000001105 femoral artery Anatomy 0.000 description 2
- 239000000314 lubricant Substances 0.000 description 2
- 239000000463 material Substances 0.000 description 2
- 238000001356 surgical procedure Methods 0.000 description 2
- 238000010009 beating Methods 0.000 description 1
- 239000000560 biocompatible material Substances 0.000 description 1
- 229920000249 biocompatible polymer Polymers 0.000 description 1
- 230000000740 bleeding effect Effects 0.000 description 1
- 238000002591 computed tomography Methods 0.000 description 1
- 230000001419 dependent effect Effects 0.000 description 1
- 230000000881 depressing effect Effects 0.000 description 1
- 239000012530 fluid Substances 0.000 description 1
- 239000007943 implant Substances 0.000 description 1
- 229910052751 metal Inorganic materials 0.000 description 1
- 239000002184 metal Substances 0.000 description 1
- 150000002739 metals Chemical class 0.000 description 1
- 230000037361 pathway Effects 0.000 description 1
- 230000002035 prolonged effect Effects 0.000 description 1
- 238000011084 recovery Methods 0.000 description 1
Images
Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
- A61F2/2427—Devices for manipulating or deploying heart valves during implantation
- A61F2/2436—Deployment by retracting a sheath
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
- A61F2/9517—Instruments specially adapted for placement or removal of stents or stent-grafts handle assemblies therefor
Definitions
- the present disclosure relates to systems for delivering a prosthesis to a desired location in the body of a patient and discloses methods for delivering and implanting a prosthesis. More particularly, the present disclosure relates to prosthetic valve introducer systems for deploying a heart valve prosthesis within a body lumen and to methods of delivering such a prosthesis to a desired location in the body,
- U.S. Patent No. 8,016,877 to Seguin et al illustrates a technique and a device for replacing a deficient heart valve by percutaneous route.
- An expandable prosthetic valve can be compressed about a catheter, inserted inside a body lumen, such as the femoral artery, and delivered to a desired location in the heart.
- a catheter containing a prosthesis in a retrograde manner through the femoral artery and into the descending aorta, over the aortic arch, through the ascending aorta and inside the defective aortic valve. This procedure can be assisted by fluoroscopic guidance. Once the position of the catheter containing the prosthesis is confirmed, a sheath containing the prosthesis can be moved proximally, allowing the valve prosthesis to self-expand.
- transapical and trans-aortic approaches for aortic valve replacement typically involving the use of an introducer port, i.e., a large-bore overtube, of a trocar.
- a crimped, framed valve prosthesis reversibly coupled to a delivery catheter can be transcatheterally advanced toward the native valve, where it can either be deployed using a balloon catheter, or, alternatively, using a self-expandable system.
- the heart valve prosthesis can have a self-expanding multi-level frame that supports a valve body with a skirt and plurality of leaflets.
- the frame can be contracted during percutaneous transluminal delivery and expanded to an hourglass shape upon deployment within the native heart valve.
- valve introducer systems for implanting a heart valve prosthesis through a trans-aortic pathway. By directly accessing the aorta, it is possible to accurately implant a prosthetic valve without the need for cardiopulmonary bypass, although the disclosed valve introducer systems can also be used with cardiopulmonary bypass. Furthermore, the valve introducer systems disclosed herein allow for one-handed deployment of the prosthetic valve, providing a quick, single-shot and accurate deployment.
- the valve introducer can include a delivery shaft with a distal tip and a tubular member to house a prosthetic valve, and a deployment element to push the prosthetic valve out of the distal tip of the delivery shaft.
- the valve introducer includes a handle with a deployment element, a deployment element housing and at least one finger gripping element connected to the deployment element housing.
- the delivery shaft can be inserted into a body lumen and advanced to a desired deployment location.
- the prosthetic valve can be deployed by pushing the deployment element in a distal direction, thereby pushing the prosthetic valve out the distal tip of the delivery shaft.
- FIG. 1 illustrates an embodiment of delivery device 100, which generally includes handle 102, delivery shaft 110, capsule 112, and distal tip 114.
- FIG. 2 shows a close up view of handle 102, which includes deployment element 104, deployment element housing 108, and finger grips 106. Handle 102 can also include access port 116.
- parts of delivery device 100 can be made from biocompatible materials, such as certain biocompatible polymers and metals known in the art.
- Deployment element 104 is used to deploy a prosthetic valve loaded into delivery device 100.
- deployment element 104 can be designed to deploy the prosthetic valve in a single shot, that is, by deploying the prosthetic valve from delivery device 100 in one smooth motion.
- the user can control the speed of deployment by the rate at which the user activates deployment element 104.
- the user may wish to reposition the prosthetic valve after beginning to deploy the prosthetic valve. The user can accomplish this by moving the entire delivery device 100 in a distal or proximal direction.
- deployment element 104 and deployment element housing 108 can be generally cylindrical in shape.
- Deployment element 104 is configured to slidably engage with deployment element housing 108, such as by a channel or groove, as illustrated in FIG. 2 .
- the circumference of deployment element 104 can also be such that it frictionally engages deployment element housing 108. This can provide controlled movement of deployment element 104 during deployment of the prosthetic valve.
- Deployment element 104 can be made of materials such as plastic or rubber to impart enough force to push the prosthetic valve out of distal tip 114, but without damaging the structural integrity of the prosthetic valve. In embodiments where the distal end of deployment element 104 contacts the prosthetic valve, the distal end of deployment element 104 can be made of a softer material to prevent damaging the prosthetic valve during deployment.
- deployment element 104 can include a feature to assist in pushing or pulling deployment element 104.
- FIG. 2 illustrates a hole or ring-shaped feature located at the proximal end of deployment element 104 to allow for insertion of a finger.
- This feature can also be saddle-shaped, or simply a flat surface, as shown in FIG. 3 .
- This feature can aid in deploying the prosthetic valve by providing tactile feel and preventing the user's finger from slipping from deployment element 104.
- the thumb can be used to push or pull deployment element 104 to deploy the prosthetic valve.
- Finger grips 106 are connected to, deployment element housing 108.
- Finger grips 106 include an interior surface formed by a hole or ring element to allow insertion of a finger, and an exterior surface for gripping. The gripping surfaces are curved to provide comfort and tactile feel.
- the index finger and middle finger can utilize finger grips 106 to steady delivery device 100 while the thumb can be used to push or pull deployment element 104 during deployment of the prosthetic valve. By grasping finger grips 106 and pushing or pulling deployment element 104 with the thumb, the user can deploy the prosthetic valve.
- Handle 102 can also include access port 116.
- Access port 116 can be used, for example, to extract air from the system, introduce fluid into the system, or insert additional surgical tools through the system and into the body lumen.
- Delivery shaft 110 can be inserted into a body lumen to deliver a prosthetic valve.
- delivery shaft 110 can be generally cylindrical in shape, with a smooth exterior surface. This can help prevent damage to the interior of the body lumen.
- Capsule 112 and distal tip 114 can be located at the distal end of delivery shaft 110.
- Capsule 112 can house a prosthetic valve.
- a collapsible and self-expanding prosthetic valve such as the one in U.S. Patent No. 7,914,569 to Nguyen et al. , can be loaded into capsule 112 prior to the surgical procedure.
- the interior of delivery shaft 110, capsule 112 and distal tip 114 can all be coated with a biocompatible lubricant, which can decrease friction with the prosthetic valve and allow a smooth exit during deployment.
- Distal tip 114 is an atraumatic tip. It is flexible to prevent damage to the interior of the body lumen, and expandable to allow it to expand from its generally tapered configuration according to the invention where the prosthetic valve is pushed out of delivery shaft 110 during deployment. Distal tip 114 is biased to a tapered configuration so that it returns to the tapered configuration after the prosthetic valve is deployed out of distal tip 114.
- distal tip 114 can be radiopaque to assist in locating distal tip 114 with medical imaging during the implantation procedure.
- distal tip 114 can be used to puncture the exterior surface of a body lumen to provide access to the interior of the body lumen, similar to a syringe.
- Deployment element 104 has a portion that extends through the interior of delivery shaft 110 that is capable of pushing the prosthetic valve out of capsule 112 and through distal tip 114 in order to deploy the prosthetic valve, In certain embodiments, deployment element 104 can also be in contact with a pushing element that extends from deployment element housing 108 through the interior of delivery shaft 110 to capsule 112 in order to push the prosthetic valve out of capsule 112 and through distal tip 114.
- FIG. 3 illustrates a prosthetic valve delivery system that is not claimed.
- Prosthetic valve 302 can be housed directly within delivery shaft 110 of delivery device 300. By pushing deployment element 104 in a distal direction, prosthetic valve 302 can be forced out of distal tip 114.
- the interior of delivery shaft 110 and distal tip 114 can be coated with a biocompatible lubricant to decrease friction with the prosthetic valve and allow a smooth exit during deployment.
- Finger grips 106 can also be provided to assist in gripping delivery device 300.
- deployment element 104 has a flat surface at its proximal end. As discussed above, this feature can take other forms, such as a saddle-shaped or ring-shaped feature. This can provide a stable surface to push when deploying prosthetic valve 302.
- deployment element 104 can be in contact with the proximal end of prosthetic valve 302, such that by pushing deployment element 104 in a distal direction, prosthetic valve 302 also moves in the distal direction. By depressing deployment element 104, prosthetic valve 302 can be pushed out of delivery device 300 through distal tip 114.
- FIG. 4 illustrates delivery device 300 that is not claimed inserted into aorta 402.
- delivery device 300 can generally be inserted into the ascending aorta. Delivery device 300 can then be advanced toward the aortic sinus, which is generally the deployment location for a prosthetic aortic valve.
- Guide wire 404 can be included as part of the delivery system to help direct delivery shaft 110 of delivery device 300 to the desired deployment location. Once in the desired location, deployment element 104 can be pushed in the distal direction, as indicated by the arrow
- FIG. 5 illustrates delivery device 300 that is not claimed after deploying prosthetic valve 302.
- prosthetic valve 302 is deployed within aortic sinus 504.
- delivery device 300 can be coupled with hemostatic valve 502.
- Delivery device 300 can be introduced into aorta 402 by inserting delivery shaft 110 through hemostatic valve 502.
- Hemostatic valve 502 can be sutured in place to aorta 402 to provide a stable access point for delivery device 300.
- Hemostatic valve 502 can also contain any bleeding that may occur during the valve implantation procedure.
- the desired valve implantation location Prior to surgery, the desired valve implantation location should be determined. This can be done with the assistance of medical imaging, such as a CT scan.
- the implantation location is generally located within aortic sinus 504 such that the distal part of prosthetic valve 302 engages the leaflets of the natural aortic valve, and the proximal part of prosthetic valve 302 engages the inner wall of the ascending aorta.
- Alternative implantation sites can be used, and the optimal implantation site can be determined by a physician for each individual patient.
- a patient's chest can be opened such that aorta 402 is exposed. This can be accomplished, for example, by a mini-sternotomy or a thoracotomy.
- Delivery shaft 110 can be inserted into aorta 402 at an insertion point.
- the aorta as defined herein, can include the exterior surface and lumen of the descending aorta, aortic arch, ascending aorta and aortic sinus.
- distal tip 114 of delivery shaft 110 can be used to puncture the surface of aorta 402 at the insertion point.
- an incision can be made and hemostatic valve 502 can be secured at the insertion point to provide an access point to aorta 402.
- a radially collapsed prosthetic valve 302 can be loaded into delivery shaft 110 or capsule 112. In certain methods, prosthetic valve 302 can be pre-loaded in delivery device 100 or 300. Delivery shaft 110 can then be inserted directly into aorta 402, or through hemostatic valve 502 into aorta 402.
- delivery shaft 110 can be advanced distally until distal tip 114 reaches the desired deployment location.
- medical imaging can be used to locate distal tip 114 of delivery shaft 110 within aorta 402 prior to deployment of prosthetic valve 302.
- Delivery shaft 110 can be moved in a proximal or distal direction to adjust the deployment location of prosthetic valve 302 so that prosthetic valve 302 can be properly implanted within aortic sinus 504.
- prosthetic valve 302 can be deployed by pushing deployment element 104 in a distal direction, thereby pushing
- prosthetic valve 302 can be a self-expanding prosthetic valve, such that it will expand to a pre-fabricated size and shape within aortic sinus 504 after being deployed.
- a balloon can be included under the prosthetic valve, and inflated to expand and deploy the prosthetic valve.
- delivery device 300 can be removed from aorta 402. If hemostatic valve 502 is used, it can be detached from aorta 402, and sutures can be used to close the insertion point.
Description
- The present disclosure relates to systems for delivering a prosthesis to a desired location in the body of a patient and discloses methods for delivering and implanting a prosthesis. More particularly, the present disclosure relates to prosthetic valve introducer systems for deploying a heart valve prosthesis within a body lumen and to methods of delivering such a prosthesis to a desired location in the body,
- Currently, replacement of a deficient cardiac valve is often performed by placing the patient under extracorporeal circulation, temporarily stopping the heart, opening the thorax (e.g., by a sternotomy), surgically opening the heart, excising the deficient valve, and then implanting a prosthetic valve in its place. This procedure generally requires prolonged patient hospitalization, as well as extensive and often painful recovery.
- Recently, minimally invasive approaches have been developed to facilitate catheter-based implantation of valve prostheses in the beating heart, intending to obviate the need for the classic sternotomy and cardiopulmonary bypass. For example,
U.S. Patent No. 8,016,877 to Seguin et al . illustrates a technique and a device for replacing a deficient heart valve by percutaneous route. An expandable prosthetic valve can be compressed about a catheter, inserted inside a body lumen, such as the femoral artery, and delivered to a desired location in the heart. Additionally,U.S. Patent No. 7,914,569 to Nguyen et al. discloses advancing a catheter containing a prosthesis in a retrograde manner through the femoral artery and into the descending aorta, over the aortic arch, through the ascending aorta and inside the defective aortic valve. This procedure can be assisted by fluoroscopic guidance. Once the position of the catheter containing the prosthesis is confirmed, a sheath containing the prosthesis can be moved proximally, allowing the valve prosthesis to self-expand. - However, in certain instances it may still be necessary to use the classic sternotomy technique. It would be desirable to avoid cardiopulmonary bypass during this procedure while still obtaining accurate positioning of the prosthetic valve,
- Other techniques for delivering prosthetic heart valves via a catheter include transapical and trans-aortic approaches for aortic valve replacement, typically involving the use of an introducer port, i.e., a large-bore overtube, of a trocar. A crimped, framed valve prosthesis reversibly coupled to a delivery catheter can be transcatheterally advanced toward the native valve, where it can either be deployed using a balloon catheter, or, alternatively, using a self-expandable system.
- With regard to the structure of the heart valve prosthesis itself,
U.S. Patent No. 7,914,569 to Nguyen et al. describes an example prosthesis for percutaneous transluminal delivery, The heart valve prosthesis can have a self-expanding multi-level frame that supports a valve body with a skirt and plurality of leaflets. The frame can be contracted during percutaneous transluminal delivery and expanded to an hourglass shape upon deployment within the native heart valve. - The present disclosure describes valve introducer systems for implanting a heart valve prosthesis through a trans-aortic pathway. By directly accessing the aorta, it is possible to accurately implant a prosthetic valve without the need for cardiopulmonary bypass, although the disclosed valve introducer systems can also be used with cardiopulmonary bypass. Furthermore, the valve introducer systems disclosed herein allow for one-handed deployment of the prosthetic valve, providing a quick, single-shot and accurate deployment.
- The valve introducer can include a delivery shaft with a distal tip and a tubular member to house a prosthetic valve, and a deployment element to push the prosthetic valve out of the distal tip of the delivery shaft. The valve introducer includes a handle with a deployment element, a deployment element housing and at least one finger gripping element connected to the deployment element housing.
- In order to deliver the valve prosthesis, the delivery shaft can be inserted into a body lumen and advanced to a desired deployment location. The prosthetic valve can be deployed by pushing the deployment element in a distal direction, thereby pushing the prosthetic valve out the distal tip of the delivery shaft.
- The accompanying figures, which are incorporated herein, form part of the specification and illustrate valve introducer systems and methods of delivering a prosthesis to a desired location in a body of a patient. Together with the description, the figures further serve to explain the principles of and allow for the making and using of the valve introducer systems and methods described herein. These figures are intended to be illustrative, not limiting. Although the disclosure is generally described in the context of these embodiments, it should be understood that it is not intended to limit the scope of the disclosure to these particular embodiments. In the drawings, like reference numbers indicate identical or functionally similar elements.
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FIG. 1 illustrates a valve introducer system including a deployment element housing and a capsule to house a prosthetic valve, according to an embodiment. -
FIG. 2 illustrates a close-up view of a handle assembly, according to an embodiment. -
FIG. 3 illustrates a valve introducer system, that is not claimed. -
FIG. 4 illustrates a valve introducer system inserted into an aorta prior to deployment of a heart valve prosthesis, that is not claimed. -
FIG. 5 illustrates a valve introducer system, including a hemostatic valve, inserted into an aorta after deployment of a heart valve prosthesis, that is not claimed - While the disclosure refers to illustrative embodiments for particular applications, it should be understood that the disclosure is not limited thereto. Modifications can be made to the embodiments described herein without departing from the scope of the present disclosure. Those skilled in the art with access to this disclosure will recognize additional modifications, applications, and embodiments within the scope of this disclosure and additional fields in which the disclosed examples could be applied. Therefore, the following detailed description is not meant to be limiting. Further, it is understood that the systems and methods described below can be implemented in many different embodiments of hardware. Any actual hardware described is not meant to be limiting. The operation and behavior of the systems and methods presented are described with the understanding that modifications and variations of the embodiments are possible given the level of detail presented.
The invention is defined in claim 1. Preferred embodiments are defined in the dependent claims. -
FIG. 1 illustrates an embodiment ofdelivery device 100, which generally includeshandle 102,delivery shaft 110,capsule 112, anddistal tip 114.FIG. 2 shows a close up view ofhandle 102, which includesdeployment element 104,deployment element housing 108, andfinger grips 106.Handle 102 can also includeaccess port 116. In certain embodiments, parts ofdelivery device 100 can be made from biocompatible materials, such as certain biocompatible polymers and metals known in the art. -
Deployment element 104 is used to deploy a prosthetic valve loaded intodelivery device 100. Generally,deployment element 104 can be designed to deploy the prosthetic valve in a single shot, that is, by deploying the prosthetic valve fromdelivery device 100 in one smooth motion. The user can control the speed of deployment by the rate at which the user activatesdeployment element 104. In certain instances, the user may wish to reposition the prosthetic valve after beginning to deploy the prosthetic valve. The user can accomplish this by moving theentire delivery device 100 in a distal or proximal direction. - In certain embodiments,
deployment element 104 anddeployment element housing 108 can be generally cylindrical in shape.Deployment element 104 is configured to slidably engage withdeployment element housing 108, such as by a channel or groove, as illustrated inFIG. 2 . The circumference ofdeployment element 104 can also be such that it frictionally engagesdeployment element housing 108. This can provide controlled movement ofdeployment element 104 during deployment of the prosthetic valve.Deployment element 104 can be made of materials such as plastic or rubber to impart enough force to push the prosthetic valve out ofdistal tip 114, but without damaging the structural integrity of the prosthetic valve. In embodiments where the distal end ofdeployment element 104 contacts the prosthetic valve, the distal end ofdeployment element 104 can be made of a softer material to prevent damaging the prosthetic valve during deployment. - In certain embodiments,
deployment element 104 can include a feature to assist in pushing or pullingdeployment element 104. For example,FIG. 2 illustrates a hole or ring-shaped feature located at the proximal end ofdeployment element 104 to allow for insertion of a finger. This feature can also be saddle-shaped, or simply a flat surface, as shown inFIG. 3 . This feature can aid in deploying the prosthetic valve by providing tactile feel and preventing the user's finger from slipping fromdeployment element 104. Generally, the thumb can be used to push or pulldeployment element 104 to deploy the prosthetic valve. - One or more finger grips 106 are connected to,
deployment element housing 108. Finger grips 106 include an interior surface formed by a hole or ring element to allow insertion of a finger, and an exterior surface for gripping. The gripping surfaces are curved to provide comfort and tactile feel. Generally, the index finger and middle finger can utilizefinger grips 106 tosteady delivery device 100 while the thumb can be used to push or pulldeployment element 104 during deployment of the prosthetic valve. By graspingfinger grips 106 and pushing or pullingdeployment element 104 with the thumb, the user can deploy the prosthetic valve. - Handle 102 can also include
access port 116.Access port 116 can be used, for example, to extract air from the system, introduce fluid into the system, or insert additional surgical tools through the system and into the body lumen. -
Delivery shaft 110 can be inserted into a body lumen to deliver a prosthetic valve. In certain embodiments,delivery shaft 110 can be generally cylindrical in shape, with a smooth exterior surface. This can help prevent damage to the interior of the body lumen.Capsule 112 anddistal tip 114 can be located at the distal end ofdelivery shaft 110.Capsule 112 can house a prosthetic valve. Generally, a collapsible and self-expanding prosthetic valve, such as the one inU.S. Patent No. 7,914,569 to Nguyen et al. , can be loaded intocapsule 112 prior to the surgical procedure. - The interior of
delivery shaft 110,capsule 112 anddistal tip 114 can all be coated with a biocompatible lubricant, which can decrease friction with the prosthetic valve and allow a smooth exit during deployment.Distal tip 114, is an atraumatic tip. It is flexible to prevent damage to the interior of the body lumen, and expandable to allow it to expand from its generally tapered configuration according to the invention where the prosthetic valve is pushed out ofdelivery shaft 110 during deployment.Distal tip 114 is biased to a tapered configuration so that it returns to the tapered configuration after the prosthetic valve is deployed out ofdistal tip 114. In certain embodiments,distal tip 114 can be radiopaque to assist in locatingdistal tip 114 with medical imaging during the implantation procedure. In certain embodiments,distal tip 114 can be used to puncture the exterior surface of a body lumen to provide access to the interior of the body lumen, similar to a syringe. -
Deployment element 104 has a portion that extends through the interior ofdelivery shaft 110 that is capable of pushing the prosthetic valve out ofcapsule 112 and throughdistal tip 114 in order to deploy the prosthetic valve, In certain embodiments,deployment element 104 can also be in contact with a pushing element that extends fromdeployment element housing 108 through the interior ofdelivery shaft 110 tocapsule 112 in order to push the prosthetic valve out ofcapsule 112 and throughdistal tip 114. -
FIG. 3 illustrates a prosthetic valve delivery system that is not claimed.Prosthetic valve 302 can be housed directly withindelivery shaft 110 ofdelivery device 300. By pushingdeployment element 104 in a distal direction,prosthetic valve 302 can be forced out ofdistal tip 114. The interior ofdelivery shaft 110 anddistal tip 114 can be coated with a biocompatible lubricant to decrease friction with the prosthetic valve and allow a smooth exit during deployment. Finger grips 106 can also be provided to assist ingripping delivery device 300. InFIG. 3 ,deployment element 104 has a flat surface at its proximal end. As discussed above, this feature can take other forms, such as a saddle-shaped or ring-shaped feature. This can provide a stable surface to push when deployingprosthetic valve 302. The distal end ofdeployment element 104 can be in contact with the proximal end ofprosthetic valve 302, such that by pushingdeployment element 104 in a distal direction,prosthetic valve 302 also moves in the distal direction. By depressingdeployment element 104,prosthetic valve 302 can be pushed out ofdelivery device 300 throughdistal tip 114. -
FIG. 4 illustratesdelivery device 300 that is not claimed inserted intoaorta 402. For trans-aortic delivery of a prosthetic aortic valve,delivery device 300 can generally be inserted into the ascending aorta.Delivery device 300 can then be advanced toward the aortic sinus, which is generally the deployment location for a prosthetic aortic valve.Guide wire 404 can be included as part of the delivery system to helpdirect delivery shaft 110 ofdelivery device 300 to the desired deployment location. Once in the desired location,deployment element 104 can be pushed in the distal direction, as indicated by the arrow -
FIG. 5 illustratesdelivery device 300 that is not claimed after deployingprosthetic valve 302. Generally,prosthetic valve 302 is deployed withinaortic sinus 504. As shown inFIG. 5 ,delivery device 300 can be coupled withhemostatic valve 502.Delivery device 300 can be introduced intoaorta 402 by insertingdelivery shaft 110 throughhemostatic valve 502.Hemostatic valve 502 can be sutured in place to aorta 402 to provide a stable access point fordelivery device 300.Hemostatic valve 502 can also contain any bleeding that may occur during the valve implantation procedure. - Methods of delivering a prosthetic valve are also disclosed but not claimed. Reference to the Figures may be used by way of example. Prior to surgery, the desired valve implantation location should be determined. This can be done with the assistance of medical imaging, such as a CT scan. For prosthetic aortic valve implantation via a trans-aortic route, the implantation location is generally located within
aortic sinus 504 such that the distal part ofprosthetic valve 302 engages the leaflets of the natural aortic valve, and the proximal part ofprosthetic valve 302 engages the inner wall of the ascending aorta. Alternative implantation sites can be used, and the optimal implantation site can be determined by a physician for each individual patient. - Generally, a patient's chest can be opened such that
aorta 402 is exposed. This can be accomplished, for example, by a mini-sternotomy or a thoracotomy.Delivery shaft 110 can be inserted intoaorta 402 at an insertion point. The aorta, as defined herein, can include the exterior surface and lumen of the descending aorta, aortic arch, ascending aorta and aortic sinus. In certain embodiments,distal tip 114 ofdelivery shaft 110 can be used to puncture the surface ofaorta 402 at the insertion point. In certain embodiments, an incision can be made andhemostatic valve 502 can be secured at the insertion point to provide an access point toaorta 402. - A radially collapsed
prosthetic valve 302 can be loaded intodelivery shaft 110 orcapsule 112. In certain methods,prosthetic valve 302 can be pre-loaded indelivery device Delivery shaft 110 can then be inserted directly intoaorta 402, or throughhemostatic valve 502 intoaorta 402. - After
delivery shaft 110 is inserted intoaorta 402,delivery shaft 110 can be advanced distally untildistal tip 114 reaches the desired deployment location. In certain methods medical imaging can be used to locatedistal tip 114 ofdelivery shaft 110 withinaorta 402 prior to deployment ofprosthetic valve 302.Delivery shaft 110 can be moved in a proximal or distal direction to adjust the deployment location ofprosthetic valve 302 so thatprosthetic valve 302 can be properly implanted withinaortic sinus 504. - Once in the proper location, in certain embodiments,
prosthetic valve 302 can be deployed by pushingdeployment element 104 in a distal direction, thereby pushing - Generally,
prosthetic valve 302 can be a self-expanding prosthetic valve, such that it will expand to a pre-fabricated size and shape withinaortic sinus 504 after being deployed. In certain methods, a balloon can be included under the prosthetic valve, and inflated to expand and deploy the prosthetic valve. - After deployment of
prosthetic valve 302,delivery device 300 can be removed fromaorta 402. Ifhemostatic valve 502 is used, it can be detached fromaorta 402, and sutures can be used to close the insertion point.
Claims (5)
- A prosthetic valve introducer system, the valve introducer comprising:
a handle (102) comprising:a deployment element housing (108),a deployment element (104), wherein the deployment element comprises a shaft with a proximal end, wherein the shaft is slidably engaged with an interior surface of the deployment element housing, andat least one finger gripping element (106) connected to the deployment element housing (104) and comprising an interior gripping surface and an exterior gripping surface, the interior gripping surface configured to allow insertion of a finger, the gripping surfaces being curved to provide comfort and tactile feel; anda delivery shaft (110) comprising a tubular member,a prosthetic valve (302), a housing capsule (112) for the prosthetic valve (302), and an atraumatic distal tip (114), biased to a tapered configuration, the distal tip (114) being flexible to prevent damage to the interior of a body lumen, and expandable, from the tapered configuration, to allow for pushing the prosthetic valve (302) out of the delivery shaft during deployment; andwherein the deployment element (104) has a portion that extends through the interior of the delivery shaft (110) that is capable of pushing the prosthetic valve (302) out of capsule (112) and through the distal tip (114) in order to deploy the prosthetic valve (302) from the delivery shaft (110),wherein the delivery shaft (110) is configured such that the delivery shaft can be advanced until distal tip (114) reaches the desired deployment location,and the system is configured such that the prosthetic valve is deployed by pushing the deployment element in a distal direction, thereby pushing the prosthetic valve out of the distal tip of the delivery shaft. - The prosthetic valve introducer system of claim 1, wherein the proximal end of the deployment element comprises a flat surface.
- The prosthetic valve introducer system of claim 1, further comprising a hemostatic valve (502) configured to provide access to a body lumen.
- The prosthetic valve introducer system of claim 1, wherein the handle further comprises an access port.
- The prosthetic valve introducer system of claim 1, wherein the prosthetic valve is a self-expanding prosthetic heart valve.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US13/557,505 US20140031923A1 (en) | 2012-07-25 | 2012-07-25 | Trans-Aortic Surgical Syringe-Type Device for Deployment of a Prosthetic Valve |
PCT/US2013/045229 WO2014018173A1 (en) | 2012-07-25 | 2013-06-11 | Trans-aortic surgical syringe-type device for deployment of a prosthetic valve |
Publications (2)
Publication Number | Publication Date |
---|---|
EP2877121A1 EP2877121A1 (en) | 2015-06-03 |
EP2877121B1 true EP2877121B1 (en) | 2022-12-21 |
Family
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Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
EP13733143.5A Active EP2877121B1 (en) | 2012-07-25 | 2013-06-11 | Trans-aortic surgical syringe-type device for deployment of a prosthetic valve |
Country Status (3)
Country | Link |
---|---|
US (1) | US20140031923A1 (en) |
EP (1) | EP2877121B1 (en) |
WO (1) | WO2014018173A1 (en) |
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Also Published As
Publication number | Publication date |
---|---|
WO2014018173A1 (en) | 2014-01-30 |
EP2877121A1 (en) | 2015-06-03 |
US20140031923A1 (en) | 2014-01-30 |
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